A Study of a GLP-1 Analogue in Patients With Type 2 Diabetes Treated With Metformin. - Full Text View

Sponsored by:	Hoffmann-La Roche
Information provided by:	Hoffmann-La Roche
ClinicalTrials.gov Identifier:	NCT00423501

Purpose

This 6 arm study will evaluate the efficacy, safety, pharmacokinetics and pharmacodynamics of multiple doses and regimens of a GLP-1 analogue in patients with type 2 diabetes who are treated with a stable dose of metformin. Patients will be randomized to receive either subcutaneous placebo, or subcutaneous GLP-1 analogue, 5mg, 10mg or 20mg weekly, or 10mg or 20mg every 2 weeks. All patients will continue on their existing metformin treatment regimen throughout the study. The anticipated time on study treatment is <3 months, and the target sample size is 100-500 individuals.

Condition	Intervention	Phase
Diabetes Mellitus, Type 2	Drug: GLP-1 Drug: Placebo	Phase II

MedlinePlus related topics: Diabetes

Drug Information available for: Metformin Metformin hydrochloride Glucagon-like peptide 1

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Parallel Assignment, Safety/Efficacy Study
Official Title:	A Double Blind, Placebo-Controlled, Dose-Ranging Study to Investigate the Effect on Glycemic Control, Safety, Pharmacokinetics and Pharmacodynamics of GLP-1 in Patients With Type 2 Diabetes Mellitus Treated With a Stable Dose of Metformin.

Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:

Absolute change from baseline in HbAlc [ Time Frame: Week 8 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Absolute change from baseline in FPG, fructosamine, body weight, fasting insulin, C-peptide, glucagon. [ Time Frame: Week 8 ] [ Designated as safety issue: No ]
Changes in lipid profile [ Time Frame: Week 8 ] [ Designated as safety issue: No ]
AEs, laboratory parameters, primary pharmacokinetic parameters [ Time Frame: Throughout study ] [ Designated as safety issue: No ]

Enrollment:	306
Study Completion Date:	November 2007

Arms	Assigned Interventions
1: Experimental	Drug: GLP-1 5mg sc weekly
2: Experimental	Drug: GLP-1 10mg sc weekly
3: Experimental	Drug: GLP-1 20mg sc weekly
4: Experimental	Drug: GLP-1 10mg sc every 2 weeks
5: Experimental	Drug: GLP-1 20mg sc every 2 weeks
6: Placebo Comparator	Drug: Placebo sc weekly

Eligibility

Ages Eligible for Study:	18 Years to 75 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

adult patients, 18-75 years of age;
type 2 diabetes mellitus, with stable metformin treatment for >=3 months;
stable weight +/-10% for >=3 months before screening.

Exclusion Criteria:

type 1 diabetes mellitus;
treatment with any anti-hyperglycemic medication other than metformin monotherapy during last 3 months;
use of weight-lowering medications in the last 3 months;
uncontrolled hypertension.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00423501

Show 49 Study Locations

Sponsors and Collaborators

Hoffmann-La Roche

Investigators

Study Director:

Clinical Trials

Hoffmann-La Roche, +1 973 235 5000

More Information

Responsible Party:	Hoffmann-La Roche ( Clinical Trials, Study Director )
Study ID Numbers:	BC20688
Study First Received:	January 17, 2007
Last Updated:	January 15, 2009
ClinicalTrials.gov Identifier:	NCT00423501
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Metabolic Diseases
Metformin
Diabetes Mellitus, Type 2
Diabetes Mellitus
Endocrine System Diseases

Endocrinopathy
Metabolic disorder
Glucose Metabolism Disorders
Glucagon-Like Peptide 1

ClinicalTrials.gov processed this record on January 16, 2009